21 st Century - Still No Standardization

Summary Standardization of anaesthetic equipment is needed for safe anaesthetic practice. Various organizations and regulatory bodies have been made throughout world to formulate and control standards for anaesthesia equipment including endotracheal tubes. All endotracheal tubes must conform to ASTM standards. This has medico-legal importance also. Regulatory bodies should look after the whole process right from the manufacturers to the actual users. The Indian Society of Anaesthesiologists promotes safe anaesthetic practice, by establishing purchase guide-linesfor equipmentsand drugs. It isworking in collaboration with World Federation of Societiesof Anaesthesiologists. Standards have made anaesthesia and critical care equipment much safer over the years. There is need to form standards for various equipment in India.


Introduction
Likeany equipment,anaesthesiaequipment should follow "Standards" in manufacture and use. All over the world Standard protocolis followed for manufacture and use of variousanaesthesia equipments. This is required for safety of anaesthesia practice. This is necessary in present Indian scenario considering increasing consumer forum cases against anaesthesiologists. In this article various aspects of standardization process is discussed in brief. Endotracheal tubes are studied as example to think over the matter of standardization. There is need of standardization of endotracheal tubes,which isone ofmost commonly used equipment used by anaesthesiologists. Various brands of endotracheal tubes studied in this article is not an end in itself but taken asan example.There is not any intention, for proving any particular brand superior or inferior. The article is not intended to judge quality of any particular brand of endotracheal tubes mentioned and studied in the article. Its quality has to be judged by individual anaesthesiologist and regulatory bodies. The purpose of this article is to draw attention of anaesthesiologists in India to bringthe role of standardization into thought process, in respect of anaesthesia equipment. Role of Indian Society of Anaesthesiologistsis also thought for as a regulatory body for safe anaesthesia practices. It is twenty first century and stillthere is no standardization.

What is "Standard"?
Standard can be defined as "Documented agreements containingtechnical or performance specifications or other precise criteria to be used consistently as rules, guidelines or definitions of characteristics, to ensure that materials, products, process and services are fit for their intended purposes" 1 .
Three typesof standardsin Anaesthesiaand Critical care: Safety standards: Minimum requirements for electrical safety and usability.
Performance safety standard: Minimum requirement forequipment performance during use.
Technical standard:Provide guidance to manufacturers and users for equipment design, construction, performance and use.

How does process of Standardization starts?
Process of standardization usually starts when a request from manufacturer, industry association, consumergroup, educationalinstitute orgovernmentalbody is made, to help with a particular safety, performance or quality issue. Initial drafts are written by working groups or adapted from other countries or from standardsof similar equipment. Nationalcommittee members are asked to comment and vote on it. Standards are developed by technical committees, subcommittees and working groups made up of representatives of manufacturers, equipmentusers, operatorsand other interested parties using a consensus approach.

Standards for Anaesthesia and Critical Care:
Most of anaesthesia and critical care standards are written by ISO TC 121 and its subcommittees, Organisation for InternationalStandardisation Technical Committee121 and IEC 62-International Electro technical Commission Committee 62. These committees look for suggestions of anaesthesiologists and intensivists, apart from engineers.

What are ISO and IEC?
ISO stands for International Organisation for Standardisation, Founded in Feb 1947, first met in London UK in 1967 2 and present headquarters in Geneva, Switzerland 3 . National standards bodies of over 140 countries formed this federation. This body has developed a series of 'standards' applicable to various aspects of economic activity -manufacturing as wellas services. Institutes that demonstrate compliance with these Standards are certified by ISO with respect to that Standard. Some examples for different certification used for different purpose are, Certification for quality-ISO9000 (QMS) series Certification for environment-ISO14000 (EMS) series, certification for occupational safety-OHSAS 18000(OHSMS) series etc.
IEC, InternationalElectrotechnical Commission, originally located in London,the commission moved to its current headquarters in Geneva in 1948 4 . It has 42 member countries. Members are drawn from principal standardization bodies from different nations. The IEC maintains advisory committees on electrical, medical andtelecommunications, electronicson electromagnetic compatibility and safety.

"Standard's" bodies and organizations across the world:
There are numerous standards writing committees and organizations across the world. Most countries have a nationalstandards body: In United States: Anesthetic and Critical Care Committee F29of American Society for Testing and Materials (ASTM) writes the standards. ASTM has a dominant roleamong standards developers inthe USA and claims to be the world's largest developer of standards.
In Canada: CSA international (formerly the Canadian Standards Association), is a global leader in development andcertification of equipment standards, InternationalOrganisation for Standardisation (ISO), the International ElectrotechnicalCommission (IEC) and the Compressed GasAssociation (CGA).
In Europe: Committee for European Normalization (CEN) and their markingis CE.

Standards in India:
Bureau of Indian Standards (BIS) is a member of "International Organisation for Standardisation (ISO)".

Bureau ofIndian Standards (BIS)/ IndianStandards
This is national standard's body in India; headquarters is in New Delhi, a member of ISO. It has a training centre is in Noida (U.P.) known as National Institute of Training for Standardisation (NITS). Na-tionalCommittees maydecide to change ormodify any of International Standards adopted for its own country. Its objectives are 5 ……… -Harmonious development of standardization, marking and quality certification.
-Evolving national strategy for standards and integrating them with growth & development of production & exports.
BIS is engaged in formulation of Indian Standards for medical equipmentand hospitalplanning. The Indian Standard is technically equivalent to ISO / IEC standard.

Whystandardization is needed in anaesthesia ?
To reduce the discripencies amongvarious manufacturers of Endotrachealtubes(ETTS), the need for minimum standards for safety in the design and construction of medicalequipment were recognized across the world.
It is medico legally important for physicianthat he has to act in accordance with specific standardsof care established by the profession for protection of the patient against unreasonable risks 6 . Jeffrey Cooper in his classic article in the journalQualityand Safetyin Health Care, reprinted in 2002, pointed out that 84% of preventable incidents were due to human error and 14% of criticalincidentsin anaesthesiawere related to equipment failure 7 .
Safety in anaesthesia practicerelates safety in various aspects like use of drugs, procedures and equipments. It involves its make and knowledge of use. Any compromise or deviation from specific standard at any levelmay introduce risk to patient safety. These deviations can creep in by oversights in design, mistakes in equipmentmanufacturer orfacility constructionand the need to produce a usable product for the price the health care system can afford, especially in developing countries. Standards provide similarity in equipment design and materials across different models and different manufacturers. The manufacturer owes his duty of care to the ultimate user and not just to the immediate purchaser. Until recently, anaesthesia and critical care equipment produced by single manufacturer had to adhere to standards of all the countries in which equipment wasdistributed. This led tothe rise in actual price of equipments. Now global standards are being harmonizedso thatmanufacturersinfuture willonly have tomanufacture equipment to oneinternationalstandard 1 .
The Global Harmonization Task Force (GHTF) was conceived in 1992 in an effort to respond to growing need for internationalharmonization in the regulation of medical devices.
By standardization, what we are really trying to do isto write the minimum requirements for the "basic safety and essential performance" for medical equipment in general or for a particular device 1 .
Endotracheal tubes (ETT)are one of mostcommonly used equipment used by anaesthesiologists throughout the world. We will like to discuss issues related with endotracheal tube's standards in Indian perspective.

Endotracheal Tubes marketed in India: Does it follow standards?
What are different standards for Endotracheal tubes?
ASTM standard requires following recommendations to bedone and printed on endotracheal tubes 8 : -Name or trademarkof manufacture or supplier -The words "oral", "nasal" or "oral/nasal" -Inside (ID) and outside (OD) diameters in millimetres -Tissue toxicity test: Implantation testing(IT) or other, with Notation Z-79or F -29 (as per testing), -Length (depth) markings in centimetres measured from patient end.
-Cautionary note suchas 'Donot reuse' or 'Single use only',if disposable -Radiopaque marker at patient end or along the fulllength.

Comparison of ETT of Different Manufacturer marketed in India
We collected some of the common brands of Endotrachealtubes available inIndian market and compared them according to ASTM standards. We chose to study one of the most commonly used tube size of 7.5 (Table: 1) Endotracheal tubesstudied from different manufacturer were compared and followingfindings were noted: 1. Some of tubes have no markings related with manufacturer / supplier on the tube. Once tube taken out of packages, one can't know which Manufacturer / supplier it belongs to (Fig 1). 3. Tubes of same size vary in their length markings at machine end i.e. 26, 27, and 30 cm (Fig 2). Take off point of pilot balloon is different in different tubes.ASTM does not comment anything on this aspect.
4. In spite of considering same internal diameter tubes of 7.5mm, most of the tubes have outer diam-eter of 10 but one tubehas outer diameter of 10.3mm (Fig 3).

What should be done to keep up to Standards?
As an expert of the subject ofAnaesthesiology it is our duty to keep ourselves updated for different equipments we use. We should know about various international standards of that equipment. As an end user it is our duty to keep the safety of patient at the top priority. Equipment safety is one of important constituent ofsafety inanesthesia.Asa purchaserand policy maker this becomes more important because it deals with multiple users and community as a whole.

Role of Regulatory bodies:
Various governmental and non-governmental bodies areresponsible for making of laws and regulations for the manufacture, use, and maintenance of various medical equipments. However, anaesthesiologists need to encourage their governmental regulatory bodies to encourage manufacturer compliance with specific standards in order to increase patient safety.Other thananaesthesiologists every hospitaland organizations should have regulations forpurchase and maintenance of various equipment of medicaluse. Role of Indian Society of Anaesthesiologists becomes important in case of Speciality of Anaesthesia. It is the National anaesthesia society and it promotes safe anaesthetic practice by establishingpurchase guidelines forAnaesthesiaequipments and drugs 9 .The Indian Society of Anaesthesiologists should discuss the several aspects of legaland other matters to standardize medical equipments. Society can be instrumentalin raising awareness about understanding standardization by its role as a forum for improvement in anaesthesia practice in India. Quality, excellence and cost-effectiveness are the interrelated factors and must be part of everyday practice in anaesthesia 10 .
We have taken endotrachealtubes as an example of one of most commonly used simple equipment by anaesthesiologists. Similarly other equipmentslike various monitors, anaesthesia machines, pipeline etc can be studied in Indian and International scenarios to improve upon our practice of anaesthesia to achieve the goalof safe anaesthesia practice. 5. Many tubes have ringmarking to help position the tube in relation to entry point into trachea i.e. vocal cords 9 . This becomes more important when EtCO 2 monitoring is not available to confirm correct positioning of tube.
6. ASTM does not comment anythingabout cuff design (contour) butit becomesimportant as it changes the contact surface area on trachea and may be of importance. In our study some of the cuffs were oval and some attend circular when inflated outside asshown in Fig 1. Its pressure and shape inside trachea in vivo is a matter of further study.
7. Place of Murphy Eye is also not fixed in relation to end of ETT.ASTM does not comment on this.